Amino Propyl Impurity / Darolutamide Impurity 8, CAS 2451299-27-5, é uma impureza de processo clorada e aminada associada à rota sintética da darolutamida, não uma entidade farmacológica definida. Com fórmula molecular C13H14Cl2N4 e massa molar de 297.18 g/mol, corresponde a um intermediário residual ou subproduto diamino diclorado, de caráter heteroaromático ou benzílico, formado em etapas de alquilação ou aminação. Sua presença é relevante para o perfil de impurezas segundo ICH Q3A e para a avaliação de potencial mutagênico conforme ICH M7. A determinação em níveis de traço normalmente exige LC-MS/MS, LC-MS de alta resolução e métodos ortogonais por HPLC-UV, com fragmentação por MS para distinguir isômeros posicionais e análogos amino relacionados.
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